Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT04607356
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2020-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia Traditional Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Treating therapists and patient will be aware of treatment. Grip strength objective measure will be performed by a clinician blinded to the participant's treatment group. All other outcome measures are patient-reported on outcome forms."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-23', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Pain Rating Scale', 'timeFrame': 'Taken at initial intake, after completion of each treatment session (up to 12 total sessions following initial evaluation), and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions', 'description': 'Change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain'}, {'measure': 'Patient-rated tennis elbow evaluation (PRTEE)', 'timeFrame': 'Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions', 'description': 'Change in score of the patient reported outcome measure (form): rating pain as well as difficulty on a scale of 0-10 with certain movements and functional activities. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100.'}, {'measure': 'Grip Strength', 'timeFrame': 'Taken at initial intake, and at the 3-week, 6-week, 3-month, and 6-month follow-up sessions', 'description': 'Assessing change in grip strength using the JAMAR dynamometer- taken with elbow straight, average of 3 measurements recorded.'}], 'secondaryOutcomes': [{'measure': 'Patient-Reported Outcome Measurement Information System version 1.2- Global Health', 'timeFrame': 'Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions', 'description': 'Looking at mental health factors'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Physical Therapy', 'Blood Flow Restriction', 'Tennis Elbow', 'Lateral Epicondylalgia'], 'conditions': ['Tennis Elbow', 'Lateral Epicondylitis']}, 'referencesModule': {'references': [{'pmid': '28259850', 'type': 'RESULT', 'citation': 'Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.'}, {'pmid': '21410544', 'type': 'RESULT', 'citation': 'Loenneke JP, Wilson JM, Wilson GJ, Pujol TJ, Bemben MG. Potential safety issues with blood flow restriction training. Scand J Med Sci Sports. 2011 Aug;21(4):510-8. doi: 10.1111/j.1600-0838.2010.01290.x. Epub 2011 Mar 16.'}, {'pmid': '19204579', 'type': 'RESULT', 'citation': 'American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.'}, {'pmid': '26463594', 'type': 'RESULT', 'citation': 'Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28.'}, {'pmid': '19253083', 'type': 'RESULT', 'citation': 'Yasuda T, Brechue WF, Fujita T, Shirakawa J, Sato Y, Abe T. Muscle activation during low-intensity muscle contractions with restricted blood flow. J Sports Sci. 2009 Mar;27(5):479-89. doi: 10.1080/02640410802626567.'}, {'pmid': '31598419', 'type': 'RESULT', 'citation': 'Day JM, Lucado AM, Uhl TL. A COMPREHENSIVE REHABILITATION PROGRAM FOR TREATING LATERAL ELBOW TENDINOPATHY. Int J Sports Phys Ther. 2019 Sep;14(5):818-829.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical effectiveness and outcomes between current evidence based clinical care and use of personalized blood flow restriction training in the treatment of lateral epicondylalgia ("tennis elbow").', 'detailedDescription': 'Background: Lateral Epicondylalgia, or "tennis elbow", has been shown to affect up to 3% of the population and is a common musculoskeletal condition which also affects military service members. This study will compare clinical effectiveness of two treatment programs in individuals with lateral elbow pain.\n\nDesign: Prospective randomized controlled clinical trial\n\nMethods: Participants, between the ages of 18-65, presenting to the NMCSD or NHCP Occupational or Physical Therapy Clinics with complaint of lateral elbow pain will be eligible for consideration to participate in this research. Patients that meet the inclusion criteria and elect to participate in the study will be randomized to either (1) a standardized, evidence based rehabilitation program or (2) an exercise volume matched group using personalized blood flow restriction (BFR) exercise.\n\nUpon entry to the program subjects will complete measurements of height, body weight, physical activity level (Marx Activity Scale), annotation of their dominant upper extremity (UE), the patient-rated tennis elbow evaluation (PRTEE) questionnaire, Numerical Pain Rating Scale (NPRS), Patient-Reported Outcome Measurement Information System version 1.2- Global Health (PROMIS scale v1.2- Global Health), and grip strength using the JAMAR dynamometer. At the end of each treatment session subjects will complete the Numerical Pain Rating Scale (NPRS) and the OMNI-Resistance Exercise Scale (OMNI-RES) rating of perceived exertion (RPE) survey.\n\nThe standard rehabilitation group will perform active wrist extension, forearm supination, and gripping. These exercises may include isometric, concentric, or eccentric forms of strengthening contingent upon clinical decision making. Specifics of exercise performance (to include magnitude of resistance and volume of exercise) will be documented in the treatment record.\n\nThe Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The Delphi PTS measures an individual\'s personalized tourniquet pressure (PTP) using doppler technology similar to a blood pressure cuff. In the BFR exercise condition, subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist.\n\nParticipants will be provided in-clinic treatment for a maximum of 12 sessions, one to three treatment sessions weekly, and may be discharged prior to that based upon shared decision making between the participant and therapist. The NPRS, grip strength, PROMIS scale v1.2- Global Health, and PRTEE will be completed at the last clinical appointment, as well as three and six-week, and three and six month follow up appointments. Twelve months following completion of occupational/physical therapy clinical care participants will be contacted and asked to complete a verbal NPRS, PROMIS scale v1.2- Global Health and the PRTEE outcome scale. Additionally, at 12 months following discharge from Physical or Occupational Therapy, the participants\' EMR will be reviewed for follow-up visits related to the same condition (LET).\n\nData Analysis: A mixed effects longitudinal model will be utilized to assess for differences in the primary outcome measures (grip strength, NPRS, and PRTEE) between the time points of intake, end of occupational/physical therapy treatment, and three and six months post completion of treatment. Secondary analysis of change in OMNI-RES RPE and NPRS during the course of treatment will also be analyzed with a mixed effects longitudinal model. Healthcare provider(s) will be analyzed as a co-variate. Microsoft Excel and SPSS will function as the main data analysis instruments.\n\nClinical Implications: Results of this study are expected to guide clinician\'s selection of rehabilitation techniques to improve outcomes (increase strength, improve function, and decrease pain), improve mission readiness by earlier return to duty, reduce healthcare service costs, and also reduce lost duty/work time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of lateral elbow pain (e.g. "tennis elbow" or wrist extensor tendinopathy)\n2. Between the ages of 18-65\n3. Elbow pain for 4 weeks or more\n\nExclusion Criteria:\n\n1. Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.\n2. Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow.\n3. Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease\n4. Current fracture in affected arm\n5. History of crush injury to affected arm\n6. Any surgery on affected arm in last 1 year\n7. Surgery within last year on contralateral upper extremity\n8. History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)\n9. Pregnancy\n10. Active infection\n11. Current cancer diagnosis/treatment\n12. Sickle cell anemia or trait\n13. Kidney dialysis\n14. History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).\n15. Inability to consent\n16. Thromboembolism\n17. Varicose veins\n18. Cardiovascular disorders\n19. Taking anti-coagulant medications\n20. Bleeding disorder\n21. Instructed by a physician or medical practitioner that they are not cleared to exercise'}, 'identificationModule': {'nctId': 'NCT04607356', 'acronym': 'BFR', 'briefTitle': 'Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia Traditional Treatment', 'organization': {'class': 'FED', 'fullName': 'United States Naval Medical Center, San Diego'}, 'officialTitle': 'Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia vs Traditional Treatment', 'orgStudyIdInfo': {'id': 'NavalMCSD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Evidence-informed care', 'description': 'Standardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises.', 'interventionNames': ['Other: Evidence-informed care']}, {'type': 'EXPERIMENTAL', 'label': 'Evidence-informed care + Blood Flow Restriction (BFR)', 'description': 'Standardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises with the addition of BFR while performing resistive exercises.', 'interventionNames': ['Device: Blood Flow Restriction (BFR)']}], 'interventions': [{'name': 'Blood Flow Restriction (BFR)', 'type': 'DEVICE', 'description': "The Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The external constriction device will be applied to the proximal aspect of an individual's limb to restrict the flow of blood into and out of the extremity at 50% of usual flow. Subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist. The Delphi PTS cuff is inflated at the start of the exercise and remains inflated throughout the exercise. Once the participant has completed an exercise, the cuff is deflated for 1 minute and the same cycle is performed for each subsequent exercise.", 'armGroupLabels': ['Evidence-informed care + Blood Flow Restriction (BFR)']}, {'name': 'Evidence-informed care', 'type': 'OTHER', 'description': 'Evidence-based resistive exercises, stretches, soft tissue mobilization and patient education for lateral epicondylalgia.', 'armGroupLabels': ['Evidence-informed care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92134', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tara Haugen, MSOT', 'role': 'CONTACT', 'phone': '570-856-4375'}], 'facility': 'Navy Medical Readiness & Training Command San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Tara Haugen, MSOT', 'role': 'CONTACT', 'email': 'tara.a.haugen.mil@mail.mil', 'phone': '570-856-4375'}, {'name': 'Michael Rosenthal, DPT', 'role': 'CONTACT', 'email': 'mrosenthal@sdsu.edu', 'phone': '619-865-8611'}], 'overallOfficials': [{'name': 'Tara Haugen, MSOT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Naval Medical Center, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Naval Medical Center, San Diego', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'LT, Physical Therapist', 'investigatorFullName': 'Tara Haugen, OTR/L, CBIS', 'investigatorAffiliation': 'United States Naval Medical Center, San Diego'}}}}